Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Evolution of the kinetics of CTC during treatment
研究概览
简要总结
Liquid biopsy is a noninvasive method for detecting and quantifying circulating tumor cells (CTCs). Thanks to ScreenCell technology, this study aims to evaluate the evolution of the number of CTCs during breast cancer follow-up.
The identification and characterization of CTCs would make it possible to obtain information on the stage and molecular characteristics of cancer during follow-up
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For all participants :
- •Female with age greater than or equal to 18 years
- •For participants with metastatic breast cancer:
- •- Patient observed with metastatic breast cancer from the outset or metastatic fall from previously treated breast cancer with change of therapeutic line at the time of inclusion.
- •For participants with non-metastatic invasive breast cancer:
- •- Patient observed with non-metastatic infiltrative breast cancer who had not received any treatment at the time of inclusion (naïve to any treatment)
- •For healthy volunteers:
- •Participant free of any cancer at the time of inclusion, confirmed using a mammogram whose results must be satisfactory, done at the latest two years before inclusion
- •Participant with no history of cancer
排除标准
- •For all participants:
- •Age less than 18 years old
- •Refusal to participate or withdrawal of consent
- •Pregnant and/or breastfeeding women
- •Discovery of a cancerous pathology (other than breast cancer for patients) during participant follow-up.
- •For healthy volunteers:
- •History of cancer
- •Detection of CTC (positive profile) during screening
研究组 & 干预措施
Healthy Donor
Participants with no prior history of cancer and confirmed to be cancer-free at the time of inclusion, as evidenced by a negative mammogram performed within two years before enrollment
干预措施: The DM/DIV ScreenCell is the experimental product studied during this research (Device)
Metastatic
Participants with metastatic breast cancer or metastatic relapse of previously treated breast cancer with change of therapeutic line at the time of study inclusion, confirmed by a POSITIVE PET-Scan
干预措施: The DM/DIV ScreenCell is the experimental product studied during this research (Device)
No metastatic
Participants with invasive breast cancer but non-metastatic, confirmed by PET scan or mammography (confirmation not mandatory)
干预措施: The DM/DIV ScreenCell is the experimental product studied during this research (Device)
结局指标
主要结局
Evolution of the kinetics of CTC during treatment
时间窗: From enrollement to the end of follow up at 9 months
Evolution of the number of CTC isolated by ScreenCell technology thanks to a blood draw during the therapeutic management of metastatic and infiltrative non-metastatic breast cancer patients. Average number of CTCs measured during the study (D0, W6, W12, W24, W36) with a tolerance of +/- 8 days for the visits
次要结局
- Molecular characterisation of CTC(From enrollement to the end of follow up at 9 months)